Prediction of Anxiety and Memory State

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06551090
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • CAMERA (Context-Aware Multimodal Ecological Research and Assessment) — OTHER
    The CAMERA platform is a multimodal, hardware-software framework for measuring brain-behavior interactions in an unstructured environment and predict ecological states. CAMERA will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy. CAMERA consists of: Wristband sensors of autonomic physiologic signals, emphasizing heart rate metrics and electrodermal activity; Smartphone usage, emphasizing natural language processing of text input for linguistic features; Subject-tracking audiovisual array, emphasizing subject vocal activity; Intracranial neural recordings, emphasizing hippocampal theta power and high-frequency activity (\~70-200 Hz).

Study Details

The purpose of this study is to look at how signals in the brain, body, and behavior relate to anxiety and memory function. This project seeks to develop the CAMERA (Context-Aware Multimodal Ecological Research and Assessment) platform, a state-of-the-art open multimodal hardware/software system for measuring human brain-behavior relationships. The R61 portion of the project is designed to develop the CAMERA platform, which will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy, as well as to build CAMERA's passive data framework and active data framework.

Key Dates

Start date
Jul 23, 2024
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: CAMERA
    Adult subjects with epilepsy will undergo noninvasive video Electroencephalography (EEG) and intracranial electrodes sampling the amygdala and hippocampus (unilateral or bilateral). A subset of subjects (n=10) will use the Context-Aware Multimodal Ecological Research and Assessment (CAMERA) platform for 2 weeks after discharge with a subset of modalities: physiologic wristband, smartphone phenotyping, ecological momentary assessment (EMA) surveys, and memory task. At unpredictable intervals, CAMERA will interrupt subjects with: (a) an audible alarm to elicit an acoustic startle response; (b) a self-reported anxiety state scale; and (c) a visuospatial memory task with threat interference. For example, participants will fill out a brief survey and play a video game several times each day and wear a wristband with sensors.

Primary Outcome Measure

Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores [ Time Frame: 1-30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Brett E Youngerman, MD
646-317-2887
Brett E Youngerman, MD (PRINCIPAL_INVESTIGATOR)

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